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FDA Approves Lower Dose of Cabazitaxel for mCRPC

The approval is based on data from a non-inferiority, multicentre, randomised, open-label PROSELICA study

On 14 September, 2017, the US Food and Drug Administration (FDA) approved a lower dose of
cabazitaxel (20 mg/m2 every 3 weeks) (JEVTANA, Sanofi-Aventis) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a
docetaxel-containing treatment regimen. Cabazitaxel (25 mg/m2 every 3 weeks) was approved for this indication in 2010.

The approval was based on data from a non-inferiority, multicentre, randomised, open-label trial (PROSELICA) of 1200 patients with mCRPC previously treated with a docetaxel-containing regimen. This trial was conducted as a post-marketing requirement to evaluate a lower dose compared with the approved dose of 25 mg/m2. Patients received either cabazitaxel 25 mg/m2 (n=602) or the 20 mg/m2 (n=598) dose.

The major safety findings, myelosuppression, infections and increased toxicity, occurred with greater frequency on the 25 mg/m2 arm compared to the lower dose. Deaths within 30 days of the last study drug dose (5.4% vs. 3.8%), and early infection-related deaths within 30 days of the treatment initiation (1.3% vs 0.7%) were more common on the 25 mg/m2 arm compared to the 20 mg/m2 arm. All of the early infection-related deaths occurred in patients greater than 60 years of age. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.

Adverse reactions and laboratory abnormalities occurring in greater than 10% of patients treated with cabazitaxel on clinical trials were neutropenia, anaemia, leukopenia, thrombocytopenia, diarrhoea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, haematuria, back pain, and anorexia. Grade 3-4 infections were reported in 20% patients on the 25 mg/m2 arm and 10% patients on the lower dose. Febrile neutropenia occurred in 9% of patients on the 25 mg/m2 arm and in 2% on the 20 mg/m2 arm. The most common reasons for dose discontinuation were fatigue and haematuria.

The recommended dose of cabazitaxel is 20 mg/m2 administered every three weeks as a one-hour intravenous infusion in combination with oral prednisone 10 mg administered daily. A dose of 25 mg/m2 can be used in select patients at the discretion of the treating healthcare provider.